Duns Number:656002163
Device Description: The WowGoHealth Control Solution should be tested on WowGoHealth meter using WowGoHealth t The WowGoHealth Control Solution should be tested on WowGoHealth meter using WowGoHealth test strips to make sure the meter and test strips are working properly.
Catalog Number
-
Brand Name
WowGoHealth Control Solution - GSH-BGM902 - Level 1
Version/Model Number
GSH-BGM902 - Level 1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
1f103174-9318-4ddf-abdc-d4c4bc1a7671
Public Version Date
July 12, 2019
Public Version Number
1
DI Record Publish Date
July 04, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |